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Transcript
APPLIED ORAL SCIENCES · IMMUNOLOGY & INFECTIOUS DISEASES · MICROBIOLOGY · MINERALIZED TISSUE BIOLOGY
Improving health through innovative
research, community care, and education
in oral and related biomedical science.
AVAILABLE TECHNOLOGY
ANTIBIOTIC ENDODONTIC FIBERS
TECHNOLOGY DESCRIPTION
VALUE PROPOSITION
The current invention describes novel endodontic fibers
comprised of a biocompatible polymer (ethylene vinyl
acetate – EVA) that is permeable to various
medications/antibiotics. Such fibers can be used, for
example, in a method for the local delivery and sustained
release of antibiotics to periodontal or intracanal
treatment sites. Despite recent advances in endodontic
instrumentation, residual bacteria are inevitably present
in
teeth
following
standard
chemomechanical
debridement during endodontic treatment. This reflects
the complex anatomy of the root canal system, as well as
the fact that many viable bacteria are present but cannot
be removed from dentinal tubules, where they may
penetrate up to 1 mm into dentin. Residual bacteria,
particularly Porphyromonas and Prevotella sp. may cause
acute reinfections (‘flare-ups’) and have been associated
with pain and abscess formation. These ‘flare-ups’
require emergency patient visits during multi-visit
treatment; systemic clindamycin is the antibiotic of
choice for their treatment in doses of approximately
2g/day. Our present clindamycin/EVA device releases
1000-fold lower levels of antibiotic locally in the root
canal, and has the ability to prevent flare-ups and pain.
The endodontic fibers enable a delivery system and
method capable of sustained, local release of any class
of medication/antibiotic following endodontic therapy,
which was not possible prior to this technology.
A
A 13mm
clindamycinEVA fiber
B
B Zone of
growth
inhibition of P.
gingivalis on
blood agar
plate
Intellectual Property
US Patents:
Canadian Patents:
European Patent:
6,712,610; granted – 3/30/04
7,331,787; granted – 2/19/2008
7,946,849; granted – 5/24/2011
2343471; granted – 12/15/2009
2370784; granted – 10/5/2010
1 165 057; granted – 7/2/2008
Inventors
Dr. Jack Gilad, DMD
Dr. Philip Stashenko, DMD, PhD
Dr. Mario Abdennour, DMD
Dr. J. Max Goodson, DDS, PhD
Dr. Michele Scrime, DMD
Contact
Sean Cotton, MEng
Technology Development Manager
T 617.892.8360
[email protected]
DEVELOPMENT STATUS
Fibers treated with the antibiotic clindamycin have
been fabricated and tested in in vitro models against
various bacterial species; all bacteria tested showed
varying degrees of inhibition, including P. intermedia, F.
nucleatum, P. micros, S. intermedius, and other
anaerobes.
Clindamycin-EVA
fibers
significantly
reduced the number of bacteria present in extracted
human teeth and demonstrated the ability to release
active drug for at least two weeks. In a clinical trial
with 57 individuals, after placement for 1-2 weeks,
clindamycin-EVA fibers completely eliminated pain and
other clinical signs of root canal failure vs. calcium
hydroxide treatment or the control group. This
technology was previously licensed to Novalar
Pharmaceuticals.
ADVANTAGES OVER CURRENT THERAPIES





Decreased need for follow-up retreatments
Fibers are biocompatible synthetic or
natural polymers – may be biodegradable
Easily placed and removed in seconds
Controlled rate of antibiotic release
Delivery of additional therapeutic agents
(i.e. anti-inflammatories)
COMMERCIAL MARKETS
Recent systematic reviews have demonstrated
that the failure rate in endodontics has
remained unchanged at ~20% in the past 4
decades, a finding supported by a recent NYU
Practice-Based Research Network (PBRN)
survey. A 10% reduction in the rate of root
canal failure (~2 million re-treatment
procedures) could potentially represent an
annual patient savings of $400 million (using
an estimate of $750 per re-treatment based
on current dental costs).
 need for
follow-ups
No increased
antibiotic
resistance
Elimination of
sensitivity to:
percussion
palpation
Eliminates
signs of:
swelling
Dr. Philip Stashenko, DMD, PhD
President and CEO; Department of Applied Oral Sciences – Forsyth
Associate Professor – Harvard School of Dental Medicine
T 617.892.8201
[email protected]